Pharmaceutical Technology ePT Weekly
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PharmTech
September 8, 2016
PHARMTECH.COM CURRENT ISSUE SUBSCRIBE FORWARD
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in this issue

Contact Lenses and Drug Delivery
DCAT Launches Networking Event in Barcelona
Aducanumab Shows Potential in Small Trial

Top Stories

Competition and Drug Pricing

Can competition block excessive pharma price hikes? EpiPen saga shows it's hard.
/ read more /


Sandoz Enbrel Biosimilar Gets Okay from FDA

Sandoz won FDA approval for its biosimilar version of Enbrel.
/ read more /


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Industry News

Contact Lenses as a Potential Drug Delivery Method for Glaucoma

Researchers at the Massachusetts Eye and Ear Infirmary developed a potential drug delivery method using a contact lens to deliver glaucoma medication.
/ read more /


Industry Groups Applaud GDUFA Agreement

GPhA and PBOA commend agreement to reauthorize Generic Drug User Fee Amendments.
/ read more /


More Industry News

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EXPERT INTERVIEW

Barry Holtz, president, iBio CMO sat down with Pharmaceutical Technology to discuss plant models in biopharmaceutical manufacturing.

WATCH NOW


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Supplier News

Aptar Pharma Forms Pact with BD to Develop Novel Autoinjector

Aptar Pharma has signed a license agreement with BD to jointly develop and bring a new autoinjector to market.
/ read more /


DCAT Launches Networking Event in Barcelona

Organization plans networking event at CPhI Worldwide to serve expanding global membership.
/ read more /


More Supplier News
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Bio/Pharma News

Aducanumab Shows Potential in Small Phase I Trial

In Phase Ib trials, Biogen's aducanumab reduced amyloid-beta in the brains of patients with Alzheimer's disease.
/ read more /


Allergan Acquires RetroSense Therapeutics

Allergan acquired clinical-stage gene-therapy company, RetroSense Therapeutics, for $60 million.
/ read more /


More Bio/Pharma News
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Risk Management Guidebook: Strategies, Tools for Success and Other Insights
Regardless of industry, whether you're an enterprise or small to mid-sized business—the common denominator is risk. This guidebook provides you with a selection of our risk-based literature, all in one place. Read on as we bring you risk management tools and strategies and how to integrate risk into standards and processes. Download Now



Regulatory News

Chinese Facility Receives Warning Letter

FDA cites two Xinxiang Tuoxin Biochemical facilities with CGMP deviations.
/ read more /

 

Quality Issues Cited at Frontida BioPharm

FDA issued a warning letter to the company for quality control violations.
/ read more /


More Regulatory News


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Enabling Formulation of Water-Soluble and Water-Insoluble Molecules Using a Lipophilic Salt Approach
Live Webcast: Tuesday, September 27 at 11:00 EDT
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FEATURED TOPICS

DRUG DEVELOPMENT

The BioRegion of Catalonia—A Unique Life-Sciences Hub in Europe

Barcelona is set to host two well-known pharmaceutical events in the upcoming calendar year: CPhI (October 4–6, 2016) and BIO Europe Spring (March 20–22, 2017). The city is the heart of the BioRegion of Catalonia, believed to be the most dynamic bioregion in Spain and one of the most active in Europe.
/ read more /

MANUFACTURING

Manufacturing and Distribution Boundaries Blur

Airlines, airports, freight forwarders, and other cold-chain partners are taking a crash course in pharma cGMPs.
/ read more /


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New Trends in Hygienic Diaphragm Valves that Improve Reliability
Live Webcast: Thursday, September 22, 2016 at 11:00 am EDT
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PROCESS DEVELOPMENT

Next Steps for Investment in Continuous Manufacturing Research

A US government report on advanced manufacturing promotes continuous manufacturing of pharmaceuticals, which has had recent commercial success but faces challenges for widespread adoption.
/ read more /

ANALYTICS

Evaluating Practical Uses of Molecular Isotopic Engineering

The authors' directed isotopic synthesis is one example of how molecular isotopic engineering can be used to predetermine the discrete isotopic ranges of biopharmaceutical products.
/ read more /


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Best Practices for Effective Excipient Sourcing and Testing
Live Webinar: Tuesday, September 20, 2016 at 11:00am EDT
Register now



AAPS Planning Guide

ICDD

ICDD's material identification databases are designed for rapid materials identification and interfaced with diffractometers and data analysis systems of the world's leading software developers and manufacturers of X-ray equipment.
AAPS Booth # 1320
/ Learn more /

Eurofins Lancaster Laboratories

As a member of Eurofins' BioPharma Product Testing Group--the largest network of harmonized bio/pharmaceutical GMP product testing laboratories worldwide--Eurofins Lancaster Laboratories supports all functional areas of bio/pharmaceutical manufacturing, including method development, microbiology, process validation and quality control throughout all stages of the drug development process.
AAPS Booth # 1221
/ Learn more /

Emergent Biosolutions

Emergent BioSolutions provides contract manufacturing services for the aseptic fill/finish of vials and syringes: liquid and lyophilized products.
AAPS Booth # 611
/ Learn more /


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Sustained-Release Formulation: Overcoming Key Challenges Like Alcohol-Induced Dose Dumping
Live Webcast: Tuesday, September 13, 2016 | 11 am EDT | 10 am CDT | 8 am PDT
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Events

ISPE Annual Meeting

September 18-21, 2016

13th Confocal Raman Imaging Symposium

September 26–28, 2016

CPhI Worldwide

October 4–6, 2016

more events

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Understanding the Relationship between Critical Quality Attributes and the Microstructure of Topical Semi-Solid Formulations
Live Webcast: Thursday, September 8, 2016 at 11 am EDT | 10 am CDT | 8 am PDT
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REFERENCE BOOKS

Pharmaceutical Technology presents its Analytical Testing Resource Guide combo

A compilation of articles in a three-handbook set covering general Analytical Testing and Stability in the manufacture, packaging, storing, and testing of formulated products.
/ Click here /

More Reference Library

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Amorphous Dispersion Drug Formulations: A Modern Simulation-Based Approach
On Demand
Learn more



eBOOKS

Bioprocessing & Sterile Manufacturing eBook

Read feature articles on accelerated scale-up for vaccine production, standards for air cleanliness classification, aseptic filling advances, a flexible approach to cleanroom design, a science-driven approach for microbial control, removing genotoxic impurities, regulatory enforcement, drug shortages, and validation of single-use shipping systems.


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